The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this clinical trial research study is to evaluate the impact of preoperative oral immunonutrition (IN) on post-operative complications in patients undergoing a cystectomy. As a secondary focus, this study will aim to develop a signature that would identify patients that would benefit the most from IN. This is a multicentric (Swiss: N=3), prospective, controlled, pragmatic, parallel-group comparative study with block randomization stratified by centers.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patient undergoing open cystectomy (for all reasons)
• Age ≥18 years
• Ability and willingness to provide informed consent documented by signature
Locations
Other Locations
Switzerland
University Hospital of Bern
NOT_YET_RECRUITING
Bern
Centre Hospitalier Universitaire Vaudois, CHUV
RECRUITING
Lausanne
Hospital of Riviera-Chablais
NOT_YET_RECRUITING
Rennaz
Contact Information
Primary
Ilaria Lucca, MD
ilaria.lucca@chuv.ch
+41213142981
Time Frame
Start Date: 2023-04-10
Estimated Completion Date: 2026-10
Participants
Target number of participants: 232
Treatments
Experimental: Immunonutrition
Seven days of preoperative oral supplementation with an immune-enhanced oral nutrition
No_intervention: No immunonutrition (control)
Standard of care
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire Vaudois
Collaborators: Insel Gruppe AG, University Hospital Bern, Hôpital Riviera-Chablais, Vaud-Valais